Non-operative Treatment in Sweden of Proximal Humeral Fratures, a Randomised Multicenter Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Union of fracture
研究概览
简要总结
Proximal humeral fractures are common especially in the elderly population. The majority of these fractures are minimally displaced and may be treated non-operatively. There is however a controversy about which fractures that need surgery and randomised trials have not been able to show a clinically important advantage in patient reported outcome measures for those operated. The trend is therefore that also displaced and comminute fractures are treated non-operatively. There is however very little scientific support for how the non-operative treatment should be designed and performed. Therefore this prospective multicenter study is aiming at investigating the benefit of a four week immobilisation orthosis as compared to early range of motion exercises for those patients not assigned for surgery one week after the trauma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The assessors are not involved in the treatment and the radiological assessment of images will be assessed with anonymyized images.
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A proximal humeral fracture verified on radiology no older than 7-10 days.
排除标准
- •Surgically treated proximal humeral fracture
- •Fracture only involving the greater tuberosity
- •Previous surgery in the fractured shoulder
- •Ongoing malignancy in the fractured shoulder
- •Neurologic disease
- •Radiating pain from the neck in the affected arm
- •Associated vascular or nerve injuries
- •Alcohol abuse
- •Unwilling to participate in the trial
结局指标
主要结局
Union of fracture
时间窗: Followed 12 months
recording of fracture union on radiological images
次要结局
- Quick DASH(12 months)
- Oxford shoulder score(12 months)
- Numerical pain reporting scale(12 months)
- Global assessment of improvement(12 months)
- Shoulder range of motion(12 months)
研究者
Lars Adolfsson
Professor
Linkoeping University
